CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 180 enrolled
Drug / intervention
Fasinumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03691974
NCT03691974Phase 2Completed

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee

Regeneron Pharmaceuticals·interventional·Posted Oct 2, 2018·Updated Mar 1, 2023

In Brief

A Phase 2 clinical trial evaluating Fasinumab and Placebo for Osteoarthritis, Knee and Osteoarthritis, Hip. Completed, enrolled 180 participants across 47 sites in 3 countries.

Detailed Summary

The primary objective of the study is to evaluate the effect of fasinumab compared to placebo on peripheral nerves in participants with pain due to Osteoarthritis (OA) of the hip or knee. The secondary objectives of the study are to: * Evaluate the efficacy of fasinumab compared to placebo in participants with pain due to OA of the hip or knee * Evaluate the safety and tolerability of fasinumab compared to placebo in participants with pain due to OA of the hip or knee * Characterize the concentrations of fasinumab in serum in participants with pain due to OA of the hip or knee * Evaluate the immunogenicity of fasinumab in participants with pain due to OA of the hip or knee.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland, United Kingdom, United States

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2, 2018
Enrollment StartOct 15, 2018
Primary CompletionJan 30, 2020
Study CompletionJan 7, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 7.8 years ago

Interventions

Fasinumabdrug

Subcutaneous (SC) every four weeks (Q4W)

Placeboother

Subcutaneous (SC) every four weeks (Q4W)